4. AndoSan compared to placebo for participants with mild‐to‐moderately active Crohn's disease.
| AndoSan compared to placebo for participants with mild‐to‐moderately active Crohn's disease | ||||||
| Patient or population: participants with mild‐to‐moderately active Crohn's disease Setting: outpatients from a single centre in Oslo, Norway Intervention: AndoSan Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with AndoSan | |||||
| Fatigue assessed with: Total Fatigue score follow‐up: 21 days | The mean fatigue score was 16.13 | MD 1.63 lower (3.51 lower to 0.26 higher) | ‐ | 100 (2 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | Total fatigue scores ranged from 0 to 33, with higher scores indicating greater fatigue. |
| Fatigue assessed with: SF‐36 Vitality follow‐up: 21 days | The mean fatigue score was 40.61 | MD 3.68 higher (1.64 lower to 9 higher) | ‐ | 100 (2 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | SF‐36 vitality subscale scores ranged from 0 to 100, with higher scores indicating greater vitality (less fatigue). |
| Quality of life ‐ not measured | ‐ | ‐ | ‐ | ‐ | This outcome was not measured. | |
| Adverse events ‐ not reported | ‐ | ‐ | ‐ | ‐ | This outcome was not reported. | |
| Serious adverse events ‐ not reported | ‐ | ‐ | ‐ | ‐ | This outcome was not reported. | |
| Withdrawal due to adverse events ‐ not reported | ‐ | ‐ | ‐ | ‐ | This outcome was not reported. | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio; | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Downgraded one level due to serious imprecision as the number of participants was small and confidence interval was wide.
2 Downgraded by one level due to high risk of bias for allocation bias (open allocation).